{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["17(18)"],"submitter":["Thomas S"],"pubmed_abstract":["<h4>Background/objectives</h4>MDG1011 is a Preferentially Expressed Antigen in Melanoma (PRAME)-specific autologous T cell receptor (TCR) T cell therapy for HLA-A*02:01-positive patients. Data from the first-in-human (FIH) clinical trial, CD-TCR-001, are reported here regarding treatment feasibility, safety, tolerability, and clinical activity of MDG1011 in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and multiple myeloma (MM).<h4>Methods</h4>Nine of thirteen enrolled patients received MDG1011 at dose levels ranging from 0.1 to 5 × 10<sup>6</sup> TCR-T cells per kg body weight. In addition to clinical assessments, immune monitoring of cytokines associated with cytokine release syndrome (CRS), presence and persistence of MDG1011, and "],"journal":["Cancers"],"pagination":["2968"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12468345"],"repository":["biostudies-literature"],"pubmed_title":["First-in-Human Study of MDG1011, a TCR-T Therapy Directed Against HLA-A*02:01-Restricted PRAME Antigen for High-Risk Myeloid and Lymphoid Neoplasms."],"pmcid":["PMC12468345"],"pubmed_authors":["Vucinic V","Bug G","Zeiser R","Prinz PU","Wermke M","Crame K","Burdek M","Tafuri A","Wagner-Drouet E","Goedkoop R","Schmitt M","Pinkernell K","Thomas S","Herr W","Raffegerst S","Mackensen A","Geiger C","Schendel DJ"],"additional_accession":[]},"is_claimable":false,"name":"First-in-Human Study of MDG1011, a TCR-T Therapy Directed Against HLA-A*02:01-Restricted PRAME Antigen for High-Risk Myeloid and Lymphoid Neoplasms.","description":"<h4>Background/objectives</h4>MDG1011 is a Preferentially Expressed Antigen in Melanoma (PRAME)-specific autologous T cell receptor (TCR) T cell therapy for HLA-A*02:01-positive patients. Data from the first-in-human (FIH) clinical trial, CD-TCR-001, are reported here regarding treatment feasibility, safety, tolerability, and clinical activity of MDG1011 in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and multiple myeloma (MM).<h4>Methods</h4>Nine of thirteen enrolled patients received MDG1011 at dose levels ranging from 0.1 to 5 × 10<sup>6</sup> TCR-T cells per kg body weight. In addition to clinical assessments, immune monitoring of cytokines associated with cytokine release syndrome (CRS), presence and persistence of MDG1011, and ","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Sep","modification":"2026-05-02T03:21:06.285Z","creation":"2026-05-02T03:12:06.288Z"},"accession":"S-EPMC12468345","cross_references":{"pubmed":["41008812"],"doi":["10.3390/cancers17182968"]}}